The purpose of this study to evaluate the safety of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.) in comparison with Fluarix Prefilled Syringe (inactivated split influenza vaccine) after single-dose intramuscular administration.
This was a randomized, open-label, active-controlled clinical study. After providing voluntary written informed consent, subjects underwent protocol-specific assessments and tests within the 4 weeks prior to administration of the study vaccine, and those who met all of the inclusion/exclusion criteria were randomized sequentially to the test group or the comparator group according to the pre-generated randomization code. To investigate the safety of the study drug with a two-dose regimen in children, the test group received another dose 28 days after the first dose. The investigator evaluated the safety and immunogenicity for each subject throughout the study. Safety assessments were performed 28 days after the first dose (Visit 4, End-of-Study Visit) for the comparator group receiving a single-dose regimen of Fluarix Prefilled Syringe, and for the test group receiving a two-dose regimen of the test drug, 28 days after the first dose (Visit 4) and 28 days after the second dose (Visit 6, End-of-Study Visit). Subjects were instructed to record any adverse event occurring after vaccination in the Patient Diary Card. For the immunogenicity assessment, an antibody titer test was performed prior to dosing at Visit 2 (baseline) and 28 days (Visit 4) after the first vaccination for both the test group and comparator group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
Second vaccination (only for the test group) of IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL
Fluarix Prefilled Syringe 0.5mL
Solicited local & general Adverse Event, Unsolicited Adverse Event
Solicited local reaction: pain, tenderness, redness, swelling, Solicited general reactions: fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia
Time frame: up to Day28(+7)
Percentage of subjects achieving seroconversion and seroprotection for HI antibody after administration of the study vaccine
Seroconversion: a pre-vaccination (Day 0) hemagglutination-inhibition (HI) antibody titer \< 1:10 and a post-vaccination (Day 28) HI antibody titer ≥ 1: 40 (Case 1), or a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer (Case 2). Seroprotection: post-vaccination (Day 28) HI antibody titer ≥ 1:40
Time frame: up to Day28(+7)
Vital signs
Time frame: up to Day28(+7)
Physical examination
Time frame: up to Day28(+7)
ECG result
Time frame: up to Day28(+7)
Clinical laboratory results
Time frame: up to Day28(+7)
GMT of HI antibody titer before vaccination and after vaccination
Geometric Mean Titer (GMT), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.
Time frame: up to Day28(+7)
GMR of HI antibody titer before vaccination and after vaccination
Geometric Mean Ratio (GMR), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer
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Time frame: up to Day28(+7)
Percentage of subjects with a pre-vaccination (Day 0) HI antibody titer < 1:40, and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer
Time frame: up to Day28(+7)